MAUDE Adverse Event Report: SPINAL ELEMENTS T INSERTER HANDLE; INTERVERTEBRAL FUSION, LUMBAR

Model Number 72-06-1 REV A

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 05/18/2018

Event Type  malfunction  

Event Description

T inserter handle broke during use.

• Brand Name: T INSERTER HANDLE
• Type of Device: INTERVERTEBRAL FUSION, LUMBAR
• Manufacturer (Section D): SPINAL ELEMENTS; marietta FL 30062
• MDR Report Key: 7553111
• MDR Text Key: 109704996
• Report Number: MW5077502
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72-06-1 REV A
• Device Lot Number: 23266005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 79